Medtronic Sofamor Danek recalls specific Grafton DBM (Flex) implants due to potential non-conformances in the Tyvek pouch from improper inspection during manufacturing.
Specific serial numbers of GraftonTM DBM product due to the potential that a step during the inspection of the outer Tyvek pouch may not have been performed according to requirements. Based on this, batches may have been released with potential non-conformances in the outer Tyvek pouch.
Medtronic Sofamor Danek is recalling specific Grafton DBM (Flex) implants because some batches may have been released with defects in the outer Tyvek pouch. This could lead to improper implant fixation during surgery. Affected patients should contact the manufacturer for details.
During manufacturing, some Grafton DBM (Flex) implants may have had the outer Tyvek pouch inspected incorrectly. This could result in the pouch not meeting quality standards, potentially affecting how the implant bonds with bone during surgery.
Patients who received the recalled Grafton DBM (Flex) implants with specific serial numbers listed in the recall notice. Surgeons and medical staff using these implants are at risk if they have not verified the serial numbers.
Check the serial numbers on the implant packaging: A57164-040, A58820-011, A57164-041, and other specific numbers listed in the recall notice. The product is a Demineralized Bone Matrix implant sold under the Grafton DBM (Flex) model.
Verify if your implant has a serial number listed in the recall notice (e.g., A57164-040, A58820-011).
The recall is due to potential non-conformances in the outer Tyvek pouch from improper inspection during manufacturing, which could affect implant fixation.
No, the recall does not require immediate discontinuation. Affected patients should contact Medtronic Sofamor Danek for further instructions.
Check the serial number on your implant packaging against the list of affected numbers provided in the recall notice.
We’ve drafted a message you can send Medtronic Sofamor Danek to request your refund or repair — edit it as you like.
Subject: Recall Z-0162-2024 — Medtronic Sofamor Danek Medtronic Sofamor Danek Hello, I own a Medtronic Sofamor Danek that is covered by recall Z-0162-2024 from Medtronic Sofamor Danek. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
